5 Best Practices to Improve Clinical Trial Oversight in Hybrid and Decentralized Clinical Trials

The clinical trial field is changing rapidly. Some of these changes have been spurred by the pandemic, while others have been in the works for several years as technologies and trial needs evolve. One of the most recent changes is the rise in hybrid and decentralized clinical trials. In this blog post, we summarize five tools and tips that can help the best practices you need to support clinical trial oversight across a hybrid decentralized clinical trial.

5 Tips and Tools to Improve Clinical Trial Oversight in Hybrid and Decentralized Clinical Trials 

As you may be aware, hybrid and decentralized clinical trials allow researchers to successfully conclude a clinical trial while conducting it partially or primarily remotely. What you may not know is that a recent EY-Parthenon survey found that respondents estimate that 50% of clinical trials will be hybrid or decentralized by 2024. While hybrid or decentralized clinical trials bring with them a host of benefits, they do introduce new difficulties based on their differences from traditional clinical trials. 

Here are five best practices to keep in mind to help mitigate these differences and enhance the benefits of hybrid and decentralized clinical trials:

1. Centralize Your Data Collection 

2. Segregate Blinded Vs. Unblinded Data

3. Communication is The Key to Success

4. Use Software To Automate Meeting Scheduling

5. Standardize Your Reporting

Centralize Your Data Collection

Hybrid or decentralized clinical trials aren’t perfect, and their most decisive benefit – the remote aspects that benefit the patients and the researchers –requires thoughtfulness and preparation to empower your team to collect and store critical clinical data.

As a starting point, we recommend selecting a centralized data collection tool that includes:

• A cloud-based system that can be accessed from each location. 

• Strong security measures to ensure that only authorized.

• An intuitive user experience that promotes adoption across all of your clinical sites. 

If you’re on the hunt for just such a system, The Cloud Concinnity Platforms has you covered. This tool was built specifically for clinical trial oversight committees and integrates with your trial’s electronic data communication platform to help centralize and systemize your data. You can learn more and sign up for a demo here.

Automate Blinded Vs. Unblinded Data Segregation

As your clinical trial is taking place across a hybrid or decentralized landscape, it’s critical to introduce automation to help you manage the segregation of blinded and unblinded data. Not only does automating data segregation replace the work that goes into the manual management of sharing blinded/unblinded data with stakeholders and participants, but it also helps to mitigate any risks that can come from manual data sharing and reporting. 

Communication Is the Key to Success

Since your research team will be communicating remotely - across cities and even time zones - strong communication guidance is a necessity for success. Given the remote aspects of hybrid decentralized clinical trials, you should anticipate higher levels of asynchronous communication – note review, comments, emails, etc. We recommend utilizing a system like Cloud Concinnity to help support these needs.

Use Software To Automate Meeting Scheduling

A key challenge for managing hybrid and decentralized trials is that your administrative team is disconnected across locations, which means getting meetings scheduled can be a bit of a pain. There’s countless back and forth, which can introduce costly delays. Instead, we recommend using available tools (like Cloud Concinnity) to automate meeting scheduling and remove the friction that comes with manually scheduling meetings. 

Standardize and Batch Your Reporting

By now, you should be aware of the benefits of centralizing your data and using automation to help eliminate some of the friction that can come from hybrid or decentralized clinical trials. Work with your team to standardize the reporting that you deliver to the clinical trial oversight committee, then use a system (like Cloud Concinnity) to automate and batch report creation. 
To best implement your next hybrid or decentralized clinical trial, you’ll need software like Cloud Concinnity, which offers remote data collection all in one place, along with the ability to communicate efficiently and virtually.

For a free demo, please reach out to us today. We’re here to help.

5 Ways to Streamline Multi-Site Clinical Trial Management

Clinical trials are complex and expensive endeavors that require researchers to track enormous amounts of data, manage multiple stakeholders/participants, and communicate efficiently - all while following protocols. And that's just single-location trials!

But what happens if your clinical trial needs to run across many different sites? Then all of this complexity increases substantially, so you'll need to streamline your multi-site clinical trial processes and procedures to ensure it is completed on budget and schedule. Use our tips below to improve your multi-site clinical trial administration.

5 Ways to Streamline Multi-Site Clinical Trial Administration

1. Use a Centralized Cloud-Based Oversight Tool

2. Automate Processes Across Sites

3. Improve Information Sharing and Communication Efficiency

4. Systematize Your Outcome Tracking 

5. Stick to the Schedule

Use a Centralized Cloud-Based Oversight Tool

One of the easiest ways to improve multi-site clinical trial administration is to ensure that you have a single source of truth for the aggregation of information from each of your locations. This enables real time oversight of protocol adherence and results tracking back oversight teams, from safety committees to DMC to sponsor and CRO administrators. Ideally, invest in a cloud-based system that can be accessed by approved individuals from any location that communicates with or replaces other tools. This will provide your team with a centralized system for managing  communications, processes, and reporting. 

Pro-tip, a software like Cloud Concinnity can help in this regard. Our cloud-based platform was built to meet the specific needs of clinical trial oversight committees. 

Automate Processes Across Sites

Introducing automation into your multi-site clinical trial administration is a must for improving the operational efficiency of multi-site trials. With automation, you can eliminate many of the manual aspects of clinical trial administration - scheduling meetings, sharing notes, creating and approving required documentation, etc. Automation can also help to eliminate errors, reduce the risk of delays and noncompliance and ensure standardization. 

Improve Information Sharing and Communication Efficiency

With many different clinicians and researchers across the sites, a strong communication platform is critically vital in efficiently administrating your multi-site clinical trial. Researchers will need to be able to communicate with each other easily and quickly. They’ll also need to be able to share and access critical data files effortlessly.

This is where using the right tool can make all the difference. Make sure your communications and confidential data are being transmitted across secure, Part 11 compliance systems. 

Systematize Your Outcome Tracking

Outcome reporting can be a significant time investment in multi-site clinical trial administration. To improve your management efficiencies, we recommend systemizing your outcome tracking and reporting. Work with all of your different locations to ensure that they are reporting outcomes in a consistent manner - one that can easily be fed into your reporting frameworks.

And make sure that those outcomes make it all the way from multiple sites to the critical safety and oversight teams charged with deciding on trial progression. A system like Cloud Concinnity can help to streamline your outcome reporting, tying outcomes and communications around them to multiple systems and locations in real time.

Stick to the Schedule

Lastly, with so many different variables occurring simultaneously in a multi-site study, it can be easy to fall behind. A consistent schedule of milestones and deadlines is critical to ensure that your team stays on track. 

Be sure to hold your team accountable to these expectations and implement systems to track progress against these milestones. 

Ready to optimize and improve your multi-site clinical trials? We can help! Our system was built to meet the needs of your multi-site clinical trial.

Contact us today for a free demo of Cloud Concinnity to learn more about how our tool can help you streamline your next trial.

Product Update: Get More Out of Your Clinical Trial Meetings

As a leading clinical trial oversight solution provider, our team of experienced subject matter experts and engineers consistently explores new features to build into the Cloud Concinnity® platform. 

In speaking with our clients, we heard time and time again that they were concerned about their meeting efficiency. They felt that with their current tools, getting everyone’s schedules aligned to set a meeting was taking too much time. It was also hard to ensure that the meetings were productive as after the meeting, they had to spend even more time transcribing and distributing accurate minutes.

Time to Maximize Your Meetings with Two New Cloud Concinnity® Product Features

From this feedback, we’re excited to announce two new features to help clinical trial managers get more out of their meetings. 

1) Intuitive Meeting Scheduling Feature 

Are you tired of sending countless emails going back and forth on meeting availability? Cloud Concinnity® has you covered!

With our new intuitive meeting scheduling tool, your team can easily sync their open availability within the tool by polling meeting participants with various possible dates and times (or ask for both availability and preference). 

Meeting participants can even respond to the poll without logging into Cloud Concinnity! Poll results are shared with the other attendees as they are received. After the survey, the meeting is scheduled and pushed to all participants’ calendars. This makes it a breeze to schedule meetings with multiple stakeholders while eliminating costly administrative time. 

2) Improvements to Meeting Minutes Editing

Capture notes, takeaways, and action items easily via the improvements we’ve made to our meeting minutes editing tool. 

Now, on the Cloud Concinnity platform, meeting attendees can simultaneously share comments and annotations on draft minutes. These can be tracked on the draft of the notes, enabling the decision-maker to finalize the minutes quickly. Employing additional Cloud Concinnity features, like integrated electronic signatures, task reminders, and workflows, the finalized minutes can be signed, appropriately shared, tagged, and securely preserved. 

What Do These Menu Enhancements Mean For You?

• Easier time scheduling meetings. 

• Shared collaboration on meeting notes. 

• More efficient communications. 

This means that your team can spend less time dealing with meetings and more time working on successfully completing your trial. Now that you know what the new features are and how they can help you, start taking advantage of them today! Your team will be more productive and efficient in no time.

Our Continued Commitment To Supporting The Clinical Trial Oversight Landscape

At Cloud Concinnity®, we are confident that the future of clinical trial oversight is digital. To support the evolving needs of clinical trials and the expectations of trial stakeholders, oversight committees need to embrace the best possible digital technologies available. If you aren’t already a Cloud Concinnity® customer, now’s the perfect time to learn more about how we help improve the success rate of clinical trials. 

If you have any suggestions for new tools or platform features that you’d like to see become part of the Cloud Concinnity platform, let us know. 

Trial Management: Five Benefits of Asynchronous Collaboration

In clinical studies, time is of the essence. Every moment counts, as any delay or misuse of time can directly affect when a potentially lifesaving drug can get to the market. Many factors can squander time during a study. Some are inevitably outside of your control, but others aren’t.

Constant in-person meetings, status checks, and message response delays can eat up valuable time in your clinical trial, distracting your team from focusing on the more significant issues. This is where asynchronous collaboration can help your team save time and finish your study successfully. This blog post breaks down everything you need to know about the benefits of asynchronous collaboration.

What is asynchronous collaboration?

First, let’s define synchronous collaboration. This is any communication where two or more people communicate in real time with immediate responses. In-person meetings, desk chats, and phone calls are examples of synchronous collaboration.

Asynchronous collaboration doesn’t occur in real time and includes forms of communication like emails, project management updates, or, depending on the context, direct messaging.

There are benefits to each type of collaboration, and both are essential to a successful trial. But not all communication needs to be synchronous. Asynchronous collaboration offers a host of benefits for trial management, as it gives your team freedom and flexibility to complete your study efficiently.

4 Benefits of Asynchronous Collaboration in Trial Management? 

1. Increase Focus Time to Increase Productivity 

   One of the biggest reasons to move to asynchronous collaboration is to give your team more time to focus on their work. With synchronous collaboration, a person’s attention is constantly being pulled in another direction. There are always meetings to attend, interruptive messages to respond to, and phone calls to pick up.

   This constant need to collaborate in real-time removes the ability of someone to focus for long periods on a particular problem. These long periods of focus are imperative for addressing the more complex issues that arise in a clinical study and ensuring that your team stays productive during the trial. Key Opinion Leaders (KOLs) on whom your trial depends, are extremely busy physicians and/or academics whose work demands uninterrupted time. Asynchronous collaboration provides everyone with space to focus on their critical work.

2. Reduce Hard and Soft Costs

   Asynchronous collaboration can help lower your trial’s operational costs by reducing the number of in-person meetings, expensive conferencing systems, and other communication distractions. Fewer meetings mean lower travel costs, lower opportunity costs from the loss of productivity (due to the number of meetings), and reduced hard costs in conference software or equipment. The combined effect of the study is lower overall costs.

3.  Increase Decision-Making Speed

   Asynchronous collaboration has the added benefit of increasing decision-making speed by clearing the lines of communication and allowing everyone to contribute.

   Not everyone may have the time, ability, or option to voice their opinion in a face-to-face or teleconference meeting. But with asynchronous collaboration, everyone can contribute, which allows for more diverse ideas and an easier job of making decisions by those in charge.

   Plus, you don’t have to wait around for everyone’s schedules to align before you can talk through a decision.

4. Facilitate Alignment on Key Initiatives 

   Asynchronous collaboration and collaboration, if done on an integrated platform, records the contributions of everyone involved and is available for all to see, aiding in  the final decision-making. This helps colleagues gain alignment on critical initiatives.

   These records also help to create a history of activities, actions and decisions for reference during the trial and auditing after.  This improves consistency and compliance. 

   These four benefits improve clinical trial efficiency, essential to implementing and completing the trial safely and effectively. 

   This efficiency will increase revenue and help those in need by getting the drugs to market faster.  In order to realize these benefits, you will need to utilize an integrated, cloud-based communications and collaboration platform.  

3 Asynchronous Best Practices

Set Deadlines and Communication Expectations

With synchronous communication, the expectation is that someone will respond immediately. But with asynchronous collaboration, things are different. There are no clear rules or guidelines on when someone should or has to respond.

Setting these guidelines is imperative to successful asynchronous collaboration, so it’s essential to set clear deadlines and expectations. Perhaps it’s responding to messages within a day or emails within 24 hours. Whatever your guidelines, set clear expectations to ensure that your study runs as smoothly as possible.

Use Labels and Tags

By the very nature of asynchronous collaboration, there will be different times when messages are sent, received, read, and responded to. Therefore, it’s important to have a system to determine if a communication is in review, needs feedback, requires input, or is approved.

This is where labels and tags come in. These tools can be instrumental in letting colleagues know when a communication has been reviewed or approved. In this way, they also help with decision-making and gaining alignment between colleagues and will help the trial run as smoothly as possible.

Standardize Processes

While asynchronous communication lacks some of the benefits of synchronous communication, it’s important to remember that asynchronous communication is also about collaboration. It’s the review and approval of information in accordance with study protocol.  Standardizing your process will save everyone time and resources and ensure safe and compliant execution. An integrated, cloud-based communications and process management platform will automate your process creating even greater efficiency.  

This is where a platform like Cloud Concinnity comes. Concinnity’s integrated, compliant, process management  platform centralizes all information & communications, standarizes, automates & tracks all required processes adding efficiency, speed and risk mitigation & driving significant positive financial impact.

Implementing Cloud Concinnity for Asynchronous Collaboration

The best way to implement asynchronous collaboration is with a platform like Cloud Concinnity. While other smart programs may offer communication options or large quantities of information, Cloud Concinnity offers a flexible, cloud-based software that is built specifically for clinical trials. It allows researchers to collaborate within the platform and syncs into other trials, ensuring the successful and timely completion of a trial through effective use of asynchronous collaboration.

If you have any questions or would like to request a demo, feel free to reach out. At Cloud Concinnity, we’re here to help.

The Future of Dose Escalation Management

Dose escalation studies have been used as a cornerstone in medical research to determine the most effective dose of a drug. They are usually part of early-stage, phase I clinical trials. But like so many things in our world, the COVID-19 pandemic changed how researchers approach dose escalation management. The immediate demand for a healthy, effective vaccine showcased the need for evolving best practices and spurred researchers to adopt new technologies.

These advances have spread beyond the COVID-19 vaccines and will likely reverberate throughout the field. So to best prepare you for the future of dose escalation management, we break down these changes and the new technologies below.

How Does Dose Escalation Work?

In phase I trials, dose escalation works by finding the most effective dose of a drug; that which prevents patients from being exposed to harmful or sub-therapeutic doses of the drug.

This is a fine line to walk.

As researchers seek to avoid harm, patients are often put on lower doses that are often sub-therapeutic. The dose amount is then increased, to better identify effective doses while minimizing any harmful effects to patients. This process requires diligent management and careful consideration of all the factors involved.

Why Is Dose Escalation Important?

If the dose is sub-therapeutic, precious time and resources are misused, and the patient isn’t given effective treatment as the dose isn’t high enough to be beneficial. On the other hand, if the amount is too high, the patients may be subjected to unnecessary risk, discomfort, and unpleasant side effects.  

Dose escalation seeks to find the effective dose by slowly escalating the doses in different patient groups. However, this requires the expertise and ability to manage and analyze the data of different patients within different groups by researchers while allowing these researchers to communicate effectively and quickly.

That’s a lot to manage! Luckily, this is where the Cloud Concinnity Platform comes in.

The Importance of Technology in Dose Escalation Management

The implementation of dose escalation in phase I clinical trials requires the close monitoring of each patient’s dose and response to these doses, along with various other factors. The necessary data to track quickly adds up. So how can technology help your team manage these factors?

Providing Patient Data at Your Fingertips

Cloud Concinnity offers a solution to these problems through an easy-to-use, cloud-based software that allows an oversight committee, such as the DMC, to see what’s happening with individual patients and their dosing. This clarity of information and detail of data is invaluable when determining the correct dosing for a patient and ensuring that a study’s resources are utilized as effectively as possible.  

It also allows committees and teams to make better decisions about whether or not the study should proceed. If a statistically significant number of patients aren’t responding to treatments or, worse, are reacting negatively, this will be readily apparent. This can save time, resources, and money in ending or reworking ineffective trials early.

Reducing Administrative Burden

Moreover, technologies like Cloud Concinnity reduce the administrative and operational complexity of dose escalation trials by allowing teams to keep track of patient data and communicate quickly and effectively. And, since this is all cloud-based, it’s available for any researcher to access while also providing a central point of access.

Increases Communication

These trials often require more meetings and communication between researchers, as the nuances in the data brought about by dose escalation spur debate or discussion between researchers. Luckily, we’ve created the ability for them to meet asynchronously with the Cloud Concinnity Platform, which saves valuable time and increases the power of the team to communicate effectively.

Standardizes and Automates Processes

Many of the changes brought about by the COVID-19 pandemic aren’t going anywhere any time soon. And while the need for the most efficient, safe, and effective trials utilizing dose escalation management was prevalent before the pandemic, they are even more critical now. Researchers are using dose escalation management techniques in various fields.

This increased focus on dose escalation management means that teams will need smarter process management software to help them navigate these studies designed to find the correct dose for a drug that can potentially save millions of lives. And the best way to manage dose escalation trials is with software like Cloud Concinnity, which provides the cloud-based flexibility and ease of communication that will help your team succeed.  

While other platforms may offer communication or documentation, Cloud Concinnity provides the security and capabilities to meet the compliance requirements of a clinical study. If you have any questions or would like to see a free demo of our software, please get in touch with us. We are here to help.

7 Ways Data Monitoring Committees Can Improve Clinical Trial Trust

Sponsors of clinical trials are under pressure to maintain patient safety and data quality, but the process is time-consuming and challenging to manage. This is where more intelligent clinical trial oversight software comes in handy. The correct clinical trial oversight software can automate many of the tasks associated with clinical trial oversight, improving sponsor trust. This blog post will discuss seven ways smarter clinical trial oversight software can enhance trust between sponsors and investigators.

Improve Communication between Sponsors and Investigators

All trust is built on effective two-way communication. By providing a central repository for clinical data and communication, clinical trial oversight software can help ensure that everyone involved is on the same page by automating email alerts and reminders. In doing so, clinical trial oversight software can help reduce the risk of missed deadlines and communication breakdowns.

Improve Clinical Trial Data Quality 

To effectively build sponsor trust, there needs to be confidence in the data collected during the trial. More innovative clinical trial oversight software can improve data quality by automating data collection and analysis. This can help ensure that collected data is accurate and complete while reducing the risk of human error in data entry and analysis.

Provide Real-Time Data Access

Another way that clinical trial oversight software can help foster sponsor trust is by providing transparent access to real-time data. This means that sponsors can view what is happening in the trial at any given time and can make decisions accordingly. This level of transparency can help to improve communication between all parties involved in the trial and help to ensure that everyone is on the same page.

Provide Data Analysis Flexibility 

With the right clinical trial oversight tool, sponsors can choose the level of detail they want to see in the data and tailor the reports to their specific needs. This customization level can help make sure that sponsors are getting the information they need when they need it. It also enables sponsors to designate access tiers based on the needs of the supporting team.

Streamline Operations

Clinical trial oversight software can automate many of the tasks associated with clinical trial management, freeing up time for sponsors to focus on other aspects of their job. This automation can help reduce the time required to complete a clinical trial and empower the sponsor to bring the clinical drug to market sooner. 

Sponsors are trusting that the sites conducting their trials are following the proper procedures to ensure patient safety and data quality. But with so many moving parts in a clinical trial, it's hard for sponsors to know what's really going on at each site. Clinical trial oversight software can help streamline these operations while providing transparency into the current stage of each clinical trial

Improve Patient Safety By Improving Data Accuracy 

It’s not just sponsors that can benefit from clinical trial oversight software; this software can also improve patient safety. Inaccurate data is one of the leading causes of patient safety issues. By offering a higher degree of data accuracy, clinical trial administrators and sponsors can feel more confident that the data they are gathering is accurate and up to date, empowering these individuals with the information they need to make swift, data-backed decisions for the trial can improve the patient experience.

Increase Data Security

The more secure the clinical trial, the more trust can be built with clinical trial sponsors. This can be done by using clinical trial oversight software that is HIPAA compliant and has been tested for security vulnerabilities. Another way to increase data security is by encrypting all data collected during the clinical trial. This will ensure that only authorized personnel can access the data and that it remains tamper-proof. 

Clinical Trial Oversight software can also help reduce the risk of fraudulent activities. Fraudulent activities can occur at any stage of a clinical trial. However, by using clinical trial oversight software, sponsors can reduce the risk of fraud by increasing transparency and visibility into all aspects of the trial. This software can also help to identify potential red flags that may indicate fraudulent activities and improve the security (and integrity) of the trial. 

Build Sponsor Trust With The Right Clinical Trial Oversight Software

The cost of a clinical trial oversight software pales compared to the rest of the study costs, especially relative to the benefit they can provide. Consider using clinical trial oversight software if you’re looking for a smarter way to manage your clinical trials. Clinical trial oversight software (like the Cloud Concinnity Platform) can help you build sponsor trust by automating many of the tasks associated with clinical trial management, improving data quality, and reducing the time required to complete clinical trials. 

Contact us today to learn more about how our clinical trial oversight software can help improve your sponsor's trust.

6 Data Security Benefits We Deliver for Clinical Trial Oversight

At Concinnity, our #1 concern is data security for clinical trial oversight. 

As the world woke up to the dawning new normal of 2022, we saw thought leaders across healthcare pointing toward a digital future. Aman Khera, the Global Head of Regulatory Strategy at Worldwide Clinical Trials, cited “Digital Health” and digital transformation as the top trends shaping clinical trial regulations in 2022, noting that everyone from the WHO to the FDA and EMA are looking closely at how digitization tools should be used, and at how data is stored and used. BCG recently proclaimed that healthcare’s new reality is dynamic, digital, and here to stay. 

Security for digital data and communication is what makes the digital future of clinical trial oversight possible.

At Concinnity, we have focused on data security from day one. We know that digital security for all stakeholders at every level of the process — from study sponsors and CRO’s all the way down to each individual study participant — is an inherent and primary need to pave the way for this digital future. It is our security features that make our platform a game-changer, by making Cloud Concinnity the  most secure platform available for clinical trial oversight management.

Concinnity is structurally designed to adhere to the highest standards of data security, including the special protections required by law for health information by HIPAA and other related regulatory requirements. 

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Here are the top 6 data security benefits we deliver for clinical trial oversight:

1. Separate Workspaces for Blinded and Unblinded Study Teams

   At the very core of clinical trial oversight is the need for certain iron-clad data separation. To ensure this, Cloud Concinnity creates a “physical” separation of blinded and unblinded data that eliminates the risk of any stakeholder sharing unblinded information. In short, we make it virtually impossible for oversight data accidents to happen. 

2. Superior UI/UX (usability) that Improves Security

   The simple, clean, intuitive user interface that makes Concinnity a joy to use also makes it more secure. Our superior UI/UX and deep structural platform integrity dramatically reduces any risk of user error and of any individual using the software incorrectly or accidentally going around the system. 

3. Patent Pending Workflow Engine that Safeguards Processes and Data

   We understand that procedures and processes are as important to data security and compliance as software structure. Manual processes by nature are subject to human error and vulnerable to the loss of institutional knowledge during staffing transitions. Our proprietary workflow engine includes features that easily automate best practice processes across a portfolio of studies, protecting data and reducing the risk of variability or non-compliance. 

4. Comprehensive Oversight Solution Protects Patient/Sponsor Data

   We built capabilities and productivity integrations that allow participants to do all of their clinical trial oversight work on a single, secure platform. This eliminates the significant risk introduced by transmission of sensitive information into and out of various non compliant applications, from email on multiple servers to scheduling, video conferencing, eSignature and document editing apps where data insecurity is rife.

5. Integrated Platform Ensures Data Integrity from trial planning all the way through regulatory approval and beyond

   Confidently create a single source of truth for your trial oversight activities that securely connects all points of information, from EDC to eTMF. Robust data integrations remove the risk of data loss, leakage, and unblinding. Automated data integrations protect clinical trial data and security on the way in, eliminating the need for manual or episodic uploads. Direct integrations with reporting and document management systems protect critical decisions and auditability on the way out. 

6. Regulatory Compliance That Goes Above and Beyond

   Cloud Concinnity is compliant with all ​​21 CFR Part 11 regulations, and maintains a host of further regulatory compliance credentials. We maintain SOC2 compliance, and use further information security elements or setup elements like 2-factor authentication for login, plus role-based and configurable permissions to control access to specific data/content/information.

The bottom line? Cloud Concinnity is by far the most secure choice to manage clinical trial oversight operations, and the only clinical trial oversight software on the market equipped to fully make the digital future of clinical trial oversight possible.